FDA.reportPublic FDA data

Duo Lumbar Interbody Fusion System

Primary DI
M7408600519
Brand
Duo Lumbar Interbody Fusion System
Company
SPINEOLOGY INC.
Model
86-05-19
Catalog number
860-0519
Device description
Duo Angled Inserter Fork
Published
2019-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190055000Duo Lumbar Interbody Fusion DeviceSpineology, Inc.2019-03-07MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7408600519PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body bone graft pouchA sterile, implantable, mesh bag designed to contain and maintain the position of bone graft materials that have been implanted into a vertebral body defect, following bone tissue removal, to treat defects typically caused by trauma, deformity, tumours, or degenerative diseases. It is made of woven/knitted non-bioabsorbable synthetic polymer(s) material. Dedicated disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(651)256-8500info@spineology.com

Regulatory Flags#

DUNS number
033014361
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7401001376Threshold Pedicular Fixation System102-88-01100-13762026-08-21
M7401001377Threshold Pedicular Fixation System102-88-02100-13772026-08-21
M7401001378Threshold Pedicular Fixation System102-88-03100-13782026-08-21
M7409200004MIS TLIF System92-02-01920-00042026-08-07
M7403030001Discectomy Set10-01-138303-00012026-07-08
M7403030002Discectomy Set10-01-139303-00022026-07-08
M7403030069Discectomy Set15-01-58303-00692026-07-08
M7403030070Discectomy Set15-01-59303-00702026-07-08
M7403030071Discectomy Set15-01-60303-00712026-07-08
M7404300035CAPTURE Facet Screw Set System70-02-008-1430-00352026-05-29
M7403030028Discectomy Set15-01-45-1303-00282026-05-28
M7403030029Discectomy Set15-01-45-2303-00292026-05-28
M7403030030Discectomy Set15-01-45-3303-00302026-05-28
M7403030031Discectomy Set15-01-45-4303-00312026-05-28
M7403030032Discectomy Set15-01-45-5303-00322026-05-28
M7403030033Discectomy Set15-01-45-6303-00332026-05-28
M7403030034Discectomy Set15-01-45-7303-00342026-05-28
M7403030035Discectomy Set15-01-45-8303-00352026-05-28
M7403030036Discectomy Set15-01-45-9303-00362026-05-28
M7403030059Discectomy Set15-01-45-10303-00592026-05-28

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